Senior PV Scientist - Case Processing

Soterius, Inc.; Mumbai; On-site; INR 1,800,000 - 3,800,000; Full time

Job summary

Soterius, Inc. is seeking a senior case processing professional to deliver high-quality end-to-end ICSR processing, Quality Review and Case Submission within a high-volume pharmacovigilance program in India.

The role includes mentoring junior team members and ensuring GVP compliance across all activities. Experience required includes 2+ years in pharmacovigilance or allied domains, with strong skills in ICSR processing, MedDRA coding, and narrative writing, using safety databases such as Argus,

Qualifications

• 2+ years of related pharmacovigilance experience
• Experience in end-to-end ICSR processing
• Proficiency in MedDRA coding and narrative writing

Responsibilities

• Perform senior-level case processing across intake, triage, submission, data entry, and follow-up.
• Own quality control of processed cases and monitor quality standards.
• Carry out/review MedDRA coding and narrative writing to a high standard.
• Manage complex and escalated cases.
• Support aggregate report and signal activities as required.
• Mentor and support junior PV Scientists and associates.
• Ensure GVP compliance and quality across all activities.
• Support inspection readiness and audits for the case processing function.

Skills

End-to-end case processing

ICSR QC ownership

MedDRA coding

Narrative writing

Safety database knowledge

Tools

Argus

LSMV

Veeva

Job description

Senior case processing professional providing high-quality end-to-end ICSR processing, Quality Review and Case Submission across the full case lifecycle within a large-volume OTC/consumer healthcare pharmacovigilance program. Supports and mentors junior team members.

Experience:

2+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains

Key Responsibilities:

• Perform senior-level case processing across intake, triage, submission, data entry, and follow-up.
• Own quality control of processed cases and monitor quality standards.
• Carry out/review MedDRA coding and narrative writing to a high standard.
• Manage complex and escalated cases.
• Support aggregate report and signal activities as required.
• Mentor and support junior PV Scientists and associates.
• Ensure GVP compliance and quality across all activities.
• Support inspection readiness and audits for the case processing function.

Key Skills:

• End-to-end case processing
• ICSR QC ownership
• MedDRA coding
• Narrative writing
• Safety database knowledge - Argus, LSMV, Veeva or equivalent